Abstract

Purpose - A PEM study of nicorandil (Ikorel™) was undertaken to assess the drug’s overall safety in everyday clinical practice.

Methods - The prescription data used covered the period December 1994 to October 1996.  The event data, which were based on a minimum observation period of 6 months, came from questionnaires returned by the prescribing general practitioners.  Incidence densities (Ids) were calculated for all events occurring during month 1, months 2-6, and the overall treatment period.  Selected events were followed up.

Results - The study was based on a cohort of 13,260 patients and 86,760 patient-months of nicorandil treatment.  Major indications for use were angina (8,744) and ischaemic heart disease (846).  Adverse reactions (258) were reported in 175 (1.3%) of patients - the most frequent being headache (58; 0.4%) and unspecified side effects (36; 0.3%).  The most common reasons for stopping treatment (excluding those confounded by indication) were headache (477; 3.5%), dizziness (88; 0.65%) and ‘not effective’ (491; 3.6%).  The number of patients still being prescribed nicorandil after 6 months was 74.3%. In those cases where an opinion on effectiveness was given, nicorandil was reported to be effective in 80% (8,713) of patients.

The event of headache/migraine was the highest ID in the first month of treatment (49.4 per 1000 patient-months) and was not confounded by indication.  Follow-up of selected events was reassuring overall; rare side effects included angioneurotic oedema and photosensitivity (3 cases each).

Conclusion - This PEM study provides information on the ‘real-world’ use of nicorandil and shows generally that the drug is safe when used in the recommended dosage.